Transfusion Requirements After Head Trauma

Traumatic Brain Injury Clinical Trial

— TRAHT  

Official title:

Transfusion Requirements After Head Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203292
• Other study ID #: 32520914.3.0000.0068
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2014
• Last updated: July 28, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age equal to or greater than 18 years

• Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission

• Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission

Exclusion Criteria:

• Glasgow coma scale equal to 3 with dilated pupils bilaterally

• Previous neurological sequelae

• Pregnant women

• Jehovah's Witnesses

• Hemorrhagic shock at randomization

• Moribund patients

• Unable to provide consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Craniocerebral Trauma
• Traumatic Brain Injury

Intervention

Behavioral:
• Liberal transfusion strategy
Patients will have red blood cells transfused only if Hb < 9.0 g/dL
• Restrictive transfusion strategy
Patients will have red blood cells transfused only if Hb < 7.0 g/dL

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin difference	Hemoglobin difference between restrictive and liberal groups	14 days	No
Secondary	Number of transfused patients		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Number of red blood cell packages transfused		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	ICU mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	Hospital mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	180 days mortality		Participants will be followed for 180 after hospital discharge	Yes
Secondary	Blood stream infection	Positive blood culture with a pathogenic microorganism	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Re-bleeding		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Intensity of measures to reduce intracranial pressure	Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	Hospital length of stay		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	ICU length of stay		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Mechanical ventilation free days	Days breathing without assistance from hospital admission to day 28.	28 days	No
Secondary	Extended Glasgow Outcome Scale at hospital discharge		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Extended Glasgow Outcome Scale after 6 months		180 days	No
Secondary	Myocardial Infarction		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Acute Respiratory Distress Syndrome		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Septic Shock		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Cerebral autoregulation	Cerebral autoregulation as measure by the transcranial doppler	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Pulsatility index	Pulsatility index as measure by the transcranial doppler	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No